L Vivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.

Device Description

The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. The LVivo platform supports also global and segmental evaluation of the LV from the parasternal Short Axis (SAX) view and the Parasternal Long Axis view (PLAX).

LVivo PLAX extends the current toolbox of the LVivo platform, providing automated calculation of LV size and function parameters from the PLAX view, for cardiac function evaluation as part of the standard echocardiographic assessment in Echo environment and point-of-care. The measurements from the PLAX view add information about the contraction of the LV, its size and wall thickness and can be used for rapid evaluation of the patient's condition in the point-of-care.

In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function and the LVivo Seamless. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.

AI/ML Overview

Here's an analysis of the acceptance criteria and study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance (Primary Study)	Reported Device Performance (Additional Dataset - LVivo PLAX)
FS	correlation >=75% vs manual measurements	r=0.79	Corr: 0.74*
LVIDd	(Not explicitly stated, but implied by 'Results acceptance considered bias and LOA as well as correlation for the calculated parameters')	N/A	Corr: 0.9, Bias: 0.3cm, LOA: -0.2, 0.9
LVIDs	(Not explicitly stated)	N/A	Corr: 0.95, Bias: 0.42cm, LOA: -0.25, 1.1
IVSD	(Not explicitly stated)	N/A	Corr: 0.72, Bias: -0.16cm, LOA: -0.47, 0.13
PWD	(Not explicitly stated)	N/A	Corr: 0.68, Bias: -0.095cm, LOA: -0.21, 0.4
LV Mass	(Not explicitly stated)	N/A	Corr: 0.94, Bias: 9.14gr, LOA: -41.6, 59.88
Automatic Analysis Rate	Not explicitly stated as acceptance criteria, but reported	82%	90%

Note: The acceptance criteria for parameters other than FS are not explicitly stated in the provided text, but the results for correlation, bias, and LOA are reported, implying these were considered for acceptance. The FS correlation of 0.74 for the additional dataset is slightly below the 0.75 acceptance criteria, but the text states "The primary end point was met" and makes an overall conclusion of substantial equivalence, implying this difference was deemed acceptable in context.

2. Sample Size Used for the Test Set and Data Provenance

Primary Clinical Validation:
- Sample Size: 121 patients
- Data Provenance: Not explicitly stated, but mentioned to be "according to GCP standards."
- Retrospective or Prospective: Not explicitly stated.
Additional Dataset (for LVivo PLAX validation):
- Sample Size: 40 patients
- Data Provenance: USA-based medical center
- Retrospective or Prospective: Not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Two sonographers.
Qualifications: Not explicitly stated beyond "sonographers."

4. Adjudication Method for the Test Set

The text states "The correlation vs average manual measurements of two sonographers." This suggests a method of averaging measurements from two experts to establish the ground truth. It is not a 2+1 or 3+1 adjudication method where a third expert breaks ties, but rather a consensus via averaging.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study done to compare human readers with and without AI assistance. The study focuses on the standalone performance of the AI against human measurements.

6. Standalone Performance Study

Yes, a standalone performance study was done. The study compares the LVivo Software Application's automated analysis results against manual measurements performed by sonographers. For the primary study, 82% of exams were automatically analyzed, and for the additional dataset, 90% were automatically analyzed, indicating standalone algorithm-only performance.

7. Type of Ground Truth Used

Expert Consensus (via averaging): The ground truth was established by "average manual measurements of two sonographers."

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. This information is typically proprietary to the manufacturer and not released in 510(k) summaries unless specifically required or relevant for substantial equivalence claims.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. This is also typically proprietary and not typically included in these types of summary documents.

Summary

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October 4, 2024

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DiA Imaging Analysis Ltd. % George Hattub Medical Device Regulatory Affairs Specialist Medicsense USA LLC 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K240553

Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: September 13, 2024 Received: September 13, 2024

Dear George Hattub:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Samuel Tike for

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240553

Device Name

LVivo Software Application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. (a)	SubmitterAddress:	George J. HattubMedicsense USA LLC291 Hillside AvenueSomerset, MA 02726ghattub@comcast.net
1. (b)	ManufacturerAddress:	DiA Imaging Analysis LtdHaEnergia Street 77Beer-Sheva, Israel 8470912
	Mfg. Phone:	Tel.: +972 77 7648318
	Contact Person:	Mrs. Michal Yaacobi
	Date:	October 3, 2024
2.	Device &ClassificationName:	Medical Image Management and Processing System -classified as Class 2 QIH, Regulation Number 21 CFR 892.2050LVivo Software Application
3.	Predicate Devices:	LVivo IQS K222970
4.	Description:	The LVivo platform is a software system for automated analysis ofultrasound examinations. Automated analysis of echocardiographicexaminations is done using DICOM movies. The LVivo platform supportsglobal and segmental evaluation of the left ventricle (LV) of the heart. Theglobal LV function is evaluated from two of the apical views: four-chamber(4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LVfunction is done from three apical views 4CH, 2CH and three chamber(3CH) and supports wall motion evaluation and strain. The LVivo platformsupports also global and segmental evaluation of the LV from theparasternal Short Axis (SAX) view and the Parasternal Long Axis view(PLAX).LVivo PLAX extends the current toolbox of the LVivo platform, providingautomated calculation of LV size and function parameters from the PLAXview, for cardiac function evaluation as part of the standard echocardiographicassessment in Echo environment and point-of-care. The measurements fromthe PLAX view add information about the contraction of the LV, its size andwall thickness and can be used for rapid evaluation of the patient's conditionin the point-of-care.In addition to the LV analysis, the cardiology toolbox includes a module forautomated evaluation of the Right Ventricular function and the LVivoSeamless. The LVivo platform includes one additional non-cardiac modulefor the measurement of the bladder volume.

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LVivo platform is intended for non-invasive processing of ultrasound 5. Indications for images to detect, measure, and calculate relevant medical parameters of Use: structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
1. Comparison of With respect to technology and intended use, DiA's LVivo Software Technological Application is substantially equivalent to its predicate devices. Based upon Characteristics: the outcomes from the risk analysis and Performance Testing Evaluation, DiA believes that the addition of LVivo PLAX module to the LVivo Software Application predicate device does not raise additional safety of efficacy concerns. The following comparison table depicts the changes.

	Submitted Device	Predicate Device
Features/Characteristics	LVivo SoftwareApplication	LVivo IQS
Product Code	same	QIH
Indication for Use	same	LVivo platform isintended for non-invasive processingof ultrasoundimages to detect,measure, andcalculate relevantmedical parameters ofstructures andfunction of patientswith suspecteddisease. In addition, ithas the ability toprovide Quality Scorefeedback
Modules	LVivo PLAX, LVivo IQS,LVivo EF, LVivo SG,LVivo SAX, LVivo RV,LVivo Seamless &LVivo Bladder	LVivo IQS, LVivo EF,LVivo SG, LVivo SAX,LVivo RV, LVivoSeamless and LVivoBladder
Automation	same	yes
Manual Adjustment	same	yes
Bi plane EF evaluation	same	yes
Simultaneous 2CH and4CH evaluation	same	yes
Off-line LV RV andBladder evaluation usingDICOM clips of anyvendor	same	yes
Automated ED and ESframes selection	same	yes
Manual ED and ES framesselection	Added for the PLAXview	no
Dynamic left ventricular	same	yes
Manual editing byuser capability	same	yes
Visually confirmresults	same	yes
Automated rejectionof false results	same	yes
Volume calculation bystandard Simpson'smethod of discs for EF	same	yes
Volume curvePresentation	same	yes
EF, Strain, SWM, RV,SAX, Bladder resultspresentation	same	yes
Enables presentation ofcardiac function resultsfor different cycles	same	yes
Algorithm	Added Supportfor PLAX view	yes
Calculation speed	same	yes
Capability or a part of abigger package (device)for LV functionevaluation and Bladder	same	yes
Segmental LongitudinalStrain Measure	same	yes
Global LongitudinalStrain Measure	same	yes
Segmental wall motionevaluation	same	yes
Operating System	Same	Windows/Linux(with Androidoption for LVivoEF)
510(k) #	Pending	K222970

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7. Performance Evaluation:

A summary of the Performance Evaluation, which was based upon wellestablished test methods, demonstrated conformity to the intended use.

The clinical validation included a set of 121 patients referred for routine transthoracic echocardiography according to GCP standards. The population was comprised of 60% male, average age of 66.5 ±17. Inclusion criteria: Age ≥18. sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 49% had Normal global LV systolic function, 27% had dilated LV, 24% had LVH, 17% had CAD.

Acceptance criteria for Fractional Shortening (FS): correlation >=75% vs manual measurements.

Results

A total of 99 exams (82%) were automatically analyzed. The correlation vs average manual measurements of two sonographers was r=0.79, the primary end point was met. Specificity and sensitivity using cutoff value of 28% were 85% and 85% respectively.

Additional Dataset

An additional dataset, with exams collected from a USA based medical center, was used for LVivo PLAX validation. The data set included 40 patients with similar inclusion\exclusion criteria as described above. The patient population comprised 67.5% (27) male, average age was 60±14 ranging from 27 to 87 years of age. BMI measurement was available for 95% (38) of patients with an average BMI of 31.6± 9.1 ranging from 18.3 to 67.

16.67% (6) had normal systolic LV function, 25% (9) had a mildly impaired LV systolic function, 33.3% (12) were moderately impaired and additional 25% (9) were severely impaired. 25% (10) of patients had dilated LV size. 25% (10) have reported to have LV hypertrophy

The LVivo PLAX was applied automatically to the clips from the 40 exams. 90% of exams were automatically analyzed. Results acceptance considered bias and limits of agreement (LOA) as well as correlation for the calculated parameters. The results are provided below:

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Results of Additional Dataset

Measurements	Sonographers Agreement	LVivo PLAX vs Sonographers
LVIDd	Corr: 0.95	Corr:0.9.
	Bias: 0.12cm	Bias:0.3cm
	LOA: -0.71, 0.46	LOA -0.2, 0.9
LVIDs	Corr: 0.94	Corr:0.95.
	Bias: -0.097cm	Bias:0.42cm
	LOA: -4.1, 3.9	LOA -0.25, 1.1
FS	Corr: 0.79	Corr:0.74*.
	Bias: 1.75%	Bias:-4%
	LOA: -12.7, 16.2	LOA -19.98, 11.96
IVSD	Corr: 0.86	Corr:0.72.
	Bias: -0.08	Bias:-0.16cm
	LOA: -0.3, 0.17	LOA -0.47, 0.13
PWD	Corr: 0.73	Corr: 0.68.
	Bias: 0.06cm	Bias:-0095cm
	LOA: -0.3, 0.4	LOA -0.21, 0.4
LV Mass	Corr: 0.9	Corr:0.94.
	Bias: -10.43gr	Bias:9.14gr
	LOA: -88,68	LOA -41.6, 59.88

Conclusion: The intended use and the technological characteristics in the current device are the same as those in the predicate device. Likewise, the modifications do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully verify the validated performance of the subject device. Therefore, DiA Imaging Analysis has concluded the LVivo Software Application is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).